A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers

NCT01675518 | Completed Phase 1

• 1 other identifier: 7991-CL-0001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.

Conditions

Healthy; Pharmacokinetics of ASP7991

Keywords

Plasma concentration; ASP7991; food effect; PTH (parathyroid hormone)

Outcome Measures

Primary Outcomes (1)

• The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs

  for 96 hours after dosing

Secondary Outcomes (3)

• Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F

  for 96 hours after dosing

• Urinary concentrations of unchanged drug: Aelast，Aelast%, CLr

  for 96 hour after dosing

• plasma parathyroid hormon concentration

  for 96 hours after dosing

Study Arms (9)

Part-1 dose 1

EXPERIMENTAL

Drug: ASP7991

Part-1 dose 2

EXPERIMENTAL

Drug: ASP7991

Part-1 dose 3

EXPERIMENTAL

Drug: ASP7991

Part-1 dose 4

EXPERIMENTAL

Drug: ASP7991

Part-1 dose 5

EXPERIMENTAL

Drug: ASP7991

Part-1 dose 6

EXPERIMENTAL

Drug: ASP7991

Part-1 placebo

PLACEBO COMPARATOR

Drug: Placebo

Part-2 fed

EXPERIMENTAL

Drug: ASP7991

Part-2 fasted

EXPERIMENTAL

Drug: ASP7991

Interventions

ASP7991 DRUG

oral

Part-1 dose 1; Part-1 dose 2; Part-1 dose 3; Part-1 dose 4; Part-1 dose 5; Part-1 dose 6; Part-2 fasted; Part-2 fed

Placebo DRUG

oral

Part-1 placebo

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
• Body weight: ≥50.0 kg, \<80.0 kg
• BMI: ≥17.6, \<26.4
• Serum corrected calcium concentration: ≥9.0mg/dL, \<10.4 mg/dL

You may not qualify if:

• Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
• Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
• Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
• A deviation from normal criteria range of 12-lead ECG (QT evaluation)
• A deviation from the normal range in clinical laboratory tests
• Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL
• History of drug allergies
• Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission
• Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)
• Concurrent or previous endocrine disorders (e.g.,hyperthyroidism, aberration in growth hormone)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Interventions

ASP7991

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

JP (1)